Executive Summary of current AMIPurdue development projects
February, 2012

Regen-CTM tissue scaffold
Eric Nauman, Mechanical Engineering Department

BioRegeneration Technologies Inc., is addressing a treatment gap for patients suffering from Osteoarthritis (OA).  While OA is the most common joint disorder affecting more than 20 million people in the United States, a large group of patients are left to manage their symptoms (e.g. pain, limited mobility) while waiting for the disease to progress to a more severe level. 

Instead of waiting for disease progression and later addressing it through complete joint replacement using metals or plastics, BioRegeneration Technologies’ treatment approach holds the promise of reversing the degeneration of tissue caused by OA. 

This technology is based on research efforts at Purdue University which have successfully developed a naturally derived Tissue Scaffold, known as InMotionTM.  Implantation of InMotionTM leads to complete restoration of cartilage tissue which include:  a) reformation of bone (hard tissue);  b) reformation of cartilage (soft tissue); and  c) a proper interface between the two. 

Extensive research using small and large animal studies, both at Purdue University and at Cornell University, has demonstrated the superior healing properties of InMotionTM.  The next step in development for this unique orthopedic restoration product, with potential to eliminate the need for joint replacements or repeated operations, is to move into human trials.  AMIPurdue is proceeding with the funding and initiation of activities needed to prove human efficacy.

For more information:  www.BioRegentech.com

 

 

     
Rapid analysis through Mass Spectrometry                            (an AMIPurdue spinout, Indiana Corporation)

Point of Care Therapeutic Drug Monitoring for Intelligent Drug Dosing
Zheng Ouyang and Graham Cooks, Biomedical Engineering and Chemistry

Therapeutic Drug Monitoring (TDM) is a process for quantifying the amount of an active drug level in the bloodstream.  Currently the practice of TDM involves blood sample collection at the point of care (POC), followed by submission of the patient’s sample to a remote clinical laboratory for processing and analysis.  Results from this current approach may take from days to a week or two before the clinician receives a report. 

Two core technologies have been developed at Purdue University which enables the creation of a real-time standalone POC TDM device.  The first technology involves miniaturization of an expensive laboratory Mass Spectrometer to create a small tabletop device (Mini-MS).  Several generations of Mini-MS devices have been developed at Purdue University over the past 15 - 20 years.  The second enabling technology takes advantage of a unique Ambient Ionization technology which has also been invented by the same group of researchers at Purdue. It is known as PaperSpray Ambient Ionization.

The AMIPurdue POC TDM device will revolutionize the practice of therapeutic drug monitoring by producing immediate determination of drug levels in the bloodstream.  By delivering TDM laboratory results in less than five minutes, at the point of care, clinicians will be able to perform accurate dose adjustments and can better personalize patient care.  In just one example, this capability will have a significant impact in improving clinical outcomes for cancer patients receiving chemotherapy.   

AMIPurdue has developed the first several steps toward achieving real-time POC for therapeutic drug monitoring which will be available in clinics, doctor’s offices and hospitals.  The first step is called the “Ion Source”, which is an electro-mechanical device mounted as a “front-end” to commercial mass spectrometers.  It uses a disposable PaperSpray cassette which uses ambient ionization to quickly analyze a blood sample for any number of small-particle ions, including many drugs undergoing pre-clinical study.  Due to a < 1 minute analysis cycle, the Ion Source can reduce the time for a traditional liquid chromatography-mass spectrometry (LC-MS) pre-clinical study by months.

The second step forward in POC TDM involves combining the Purdue mini-MS technology with the PaperSpray disposable cassette in a single desktop device.  This first-of-in-kind Mini-MS/PaperSpray device will be on display in March, 2012 at Pittcon in Orlando, Florida.  Visitors to the Conference will be able to witness a desk-top computer size Mini-MS with the PaperSpray ion-source front end which can analyze a blood sample in less than 30 seconds using ambient ionization, eliminating typical sample preparation required for LC-MS.

For more information:  www.QuantIontech.com

 

 

      
        Reviving Speech & Improving Lives                                (an AMIPurdue spinout, Indiana Corporation)

Speech enhancement for Parkinson’s patients
Jessica Huber, Speech, Language, and Hearing Sciences Department
Parkinson's disease (PD) is a degenerative disorder of the central nervous system that affects more than 1.5 million Americans.  Patients with Parkinson’s disease experience gradual degeneration of motor skills along with other physiological functions such as speech.  Recent studies estimate 89% of patients with PD suffers from voice and speech disorders.  A common voice and speech disorder is hypophonia, which is marked by disruption of communicability because patients are speaking in a very soft voice, barely above a whisper.

To address hypophonia and improve communication ability of patients with PD, researchers at Purdue University have developed the SpeechViveTM device.  SpeechViveTM takes advantage of the Lombard Effect, which is an involuntary response to speak louder in a noisy environment.  Subsequent NIH sponsored clinical studies, involving 39 human PD patients, has demonstrated the effectiveness of SpeechViveTM to immediately increase vocal loudness and improve speech clarity in patients with PD.

 Treatment with SpeechViveTM differs from existing treatment plans in that it takes place during daily living activities, outside of what could be considered “traditional” therapy paradigms.  Individuals with Parkinson’s disease wear the device in natural communication contexts (speaking with family and friends, over the telephone, etc.), while achieving a louder, clearer, and more intelligible voice.  Desensitization to the SpeechViveTM masking cue has not been observed in a 3 year clinical trial.  Additionally, some patients with Parkinson’s disease have altered their speech behavior due to the SpeechViveTM such that improved speech (intensity and clarity) is retained days to weeks after discontinuing the use of the SpeechViveTM.

AMIPurdue is in the late stages of completing the medical device commercial design and development and is preparing to submit a 510K to the FDA for approval.

For more information:  www.SpeechVive.com

 

 

 

 This special feature by Sports Illustrated Magazine discussed the success by Purdue University researchers in demonstrating the cumulative damage caused by numerous “smaller” non-concussive football helmet hits; “The hits no one is noticing”.  These helmet impacts normally go unnoticed since they do not manifest the classical symptoms of concussion, such as immediate disorientation.  However using fMRI technology, coupled with cognitive testing, Purdue Researchers have been able to correlate the number of head impacts during a football game or practice (measured using telemetry and sensors placed in the player’s helmet) with a decrease in brain activities and a degeneration of cognitive skills.  The Purdue study definitively established that an accumulation of smaller hits to the helmet result in a type of brain injury which translates into a significant decline in the players’ cognitive capability during the football season.  Moreover, the study clearly demonstrated that current helmet designs are not effective in protecting players from injury during these small, but cumulative impacts.

In order to address this large-scale health issue, Researchers at Purdue University have developed ImpactGuardTM, a new material with a proprietary structural design which provides a comprehensive level of protection for the brain when subjected to all types of potentially serious sports-related impacts.  Impacts which occur at a high concussive force or multiple successive hits at lower impact are all significantly reduced using the ImpactGuardTM material and structural design.  ImpactGuardTM has a broad spectrum of energy absorption capabilities and thus will protect players from both high-impact situations as well many multiple low-impact hits. 

AMIPurdue-sponsored development has entered the final testing phase of ImpactGuardTM and the results are extraordinary.  A 10X decrease in external force transmitted to the brain using a helmet as tested and fitted with the ImpactGuardTM structural material has been demonstrated.  In testing of ImpactGuardTM, the unique structural design and material has been demonstrated equally effective  in military helmet performance against direct impact.  It is expected from strong empirical data that blast wave injuries will be significantly reduced as well.

 

 

 

Radiation therapy (radiotherapy) is the second most successful cancer treatment method, next to resection surgery.  More than half of all cancer patients need radiotherapy at some stage during their treatment.  In radiation therapy, cancer cells are destroyed using high-energy photons.  Inside the cells, these photons induce DNA damage by creating reactive oxygen molecules (free radical damage).  In addition to accurate delivery of the radiation the efficacy of radiation therapy depends on the concentration of oxygen in solid tumors.  Unfortunately, the center part of many solid tumors contain a hypoxic region (areas with low oxygen content) that is particularly resistant to radiation therapy.  In a hypoxic region the efficacy of radiotherapy may be reduced to less than half of that compared to non-hypoxic regions. 

To address the presence of hypoxic regions, engineers at Purdue University have developed a device, now known as the Implantable Micro Oxygen Generator (IMOG).  Approximately the size of a single grain of rice, the IMOG is implanted into the hypoxic tumor through a large-bore needle or catheter.  Because of its small size, the IMOG can be safely implanted using techniques similar to implanting radiotherapy seeds (brachytherapy) or fiducial markers.  Once implanted inside the tumor, IMOG generates oxygen by inducing a breakdown of water molecules (creating hydrogen and oxygen gas).  This conversion of water to oxygen gas occurs because IMOG is powered externally using ultrasound, delivered from outside the body.  The ultrasound energy can be applied either prior to or during radiotherapy.  With the ability to generate oxygen, both on-demand and right where it is needed (localized), the IMOG technology is distinct from other approaches for addressing hypoxia.